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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00486-1
Product Name/Description ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)

ARTG Number: 139591
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/04/2014
Responsible Entity Siemens Ltd
Reason/Issue The following issues may occur when using the stress echo feature:
- Shorter-than-expected clips may occur when using systolic-only captures with heart rates at approximately 120bpm (beats per minute) and higher. This computational error may occur at any heart rate; but the system produces a smaller error for lower heart rates. The issue may also cause the system to change from systolic-only captures to full beat (R-R).
- Intermittently, some post-exercise clips may not be captured during continuous capture acquisition.
- Post-exercise clips marked for deletion (unselected clips) may be restored to the study after cycling power to the system.

The potential risk to the patient may be a repeated stress echo study.
Recall Action Recall for Product Correction
Recall Action Instructions A software update will be provided to correct this problem.

End users are advised to avoid the potential risks associated with this issue by:
- Discontinue use of the stress echo feature with software version 3.5
- For studies acquired with the systolic only captures, review all patient studies on exams performed after the software revision 3.5 was installed.
Contact Information 1800 310 300 - Siemens Technical Support Centre